Label: BIOMAX USA ANTIBACTERIAL HAND WASH- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 77369-905-16 - Packager: Biomax Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient:
- Purpose
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Other ingredients:..............99.78%
Aqua/Water/Eau, Cocamidopropyl Betaine, PEG-150-distearate, Cocamide MEA, Alternifolia (Tea Tree Leaf Oil), Glycerin, Menthol, Menthyl Lactate, Parfum (Fragrance), Tetrasodium EDTA, Mica, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate, Citric Acid, CI 42090 (FD&C Blue 1).
- Uses
- Warnings
- Directions
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SPL UNCLASSIFIED SECTION
HEALTHCARE
Refreshing deep cleanser
NATURALLY CLEAN | SULFATE-FREE | PARABEN-FREE
Wash away dirt and grime with Tea Tree Hand Soap. This refreshing hand wash with tea tree oil deep cleans hands and invigorates the senses with the reviving scent of tea tree and peppermint.
Fragrance: The reviving scent of tea tree provides an invigorating aromatherapy experience like no other.
Ingredient Spotlight: Contains the famous Tingle Complex-a blend of tea tree and peppermint that leaves a cooling, "tingling" sensation. Tea tree oil is a natural antiseptic and germicide with healing properties.
Manufactured by:
Biomax Cosmetics Inc.
Houston, TX
www.biomaxcosmetics.com
MADE IN USA
- Packaging
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INGREDIENTS AND APPEARANCE
BIOMAX USA ANTIBACTERIAL HAND WASH
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77369-905 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) COCO MONOETHANOLAMIDE (UNII: C80684146D) TEA LEAF OIL (UNII: VC855RRT77) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) EDETATE SODIUM (UNII: MP1J8420LU) MICA (UNII: V8A1AW0880) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) MAGNESIUM NITRATE (UNII: 77CBG3UN78) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77369-905-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/26/2020 Labeler - Biomax Cosmetics (084032031) Establishment Name Address ID/FEI Business Operations Biomax Cosmetics 084032031 manufacture(77369-905)
